Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

This study has been terminated.

( stopped due to slow recruitment and no effect )

First Received: January 25, 2007 Last Updated: November 20, 2009 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00427583

Purpose

This study assesses the safety and efficacy of imatinib mesylate treatment of patients with malignant peripheral nerve sheath tumors

Condition	Intervention	Phase
Malignant Peripheral Nerve Sheath Tumors	Drug: imatinib mesylate	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-label Multicenter Phase II Study of Imatinib Mesylate Treatment of Patients With Malignant Peripheral Nerve Sheath Tumors

Resource links provided by NLM:

Genetics Home Reference related topics: neurofibromatosis type 1

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Response rate assessed by a Tumor MRI scan every 6 weeks or if clinically indicated. [ Time Frame: Every 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to progression assessed by an MRI scan. [ Time Frame: Every 36 weeks ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Every 36 weeks ] [ Designated as safety issue: No ]
Safety and tolerability assessed by abnormal lab values (hematology, biochemistry, urinalysis), by physical examination and vital signs [ Time Frame: Every 36 weeks ] [ Designated as safety issue: No ]

Enrollment:	11
Study Start Date:	May 2006
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
STI571: Experimental	Drug: imatinib mesylate

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Patients ≥18 years of age
Histologically documented diagnosis of malignant MPNST
Unresectable local MPNST or metastatic MPNST and therefore incurable with any conventional multimodality approach Life expectancy of at least 6 months.

Exclusion criteria:

Patient has received any other investigational agents within 28 days of first day of study drug dosing.
Chemotherapy and or radiotherapy in between the last 6 weeks before study entry, surgery in between the last 14 days before study entry.
Female patients who are pregnant or breast feeding or women of child bearing potential who are not using a highly effective method of birth control.
Known CNS metastases

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427583

Locations

Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Berlin, Germany

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

Novartis Pharmeceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CSTI571BDE57
Study First Received:	January 25, 2007
Last Updated:	November 20, 2009
ClinicalTrials.gov Identifier:	NCT00427583 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Malignant peripheral nerve sheath tumors (MPNSTs)
adult patients with neurofibromatosis type 1 (NF1)
Imatinib mesylate

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Imatinib
Neoplasms
Neuromuscular Diseases
Therapeutic Uses
Peripheral Nervous System Diseases
Peripheral Nervous System Neoplasms
Nerve Sheath Neoplasms
Nervous System Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010